Associate Regulatory Operations Specialist (Remote)

About the position

The Associate Regulatory Operations Specialist at Medtronic will support product release and regulatory submissions for both US and international markets. This role is crucial in ensuring compliance with regulations and internal procedures, contributing to the overall mission of improving healthcare access and equity. The position involves a variety of regulatory operations activities, including technical documentation, UDI submissions, and collaboration with cross-functional teams to enhance patient outcomes.

Responsibilities

• Understand and operate within regulatory guidelines on electronic submissions and internal procedures.
• Review and approve requests for product release and resolve blocked orders to ensure timely delivery of products.
• Keep systems of record updated with accurate information pertaining to regulatory work.
• Partner with team members and customers to solve problems.
• Provide formatting and publication expertise to agency submissions.
• Maintain and update assigned standard operating procedures, policies, and user guides as needed.
• Help train on Regulatory Affairs systems and procedures, providing routine problem resolution.
• Support data collection and management for UDI submissions in US and international markets.
• Assist with special projects, including data collection, analysis, and presentation of results.
• Foster relationships across functional groups to share best practices.

Requirements

• Bachelor's Degree in a relevant field.
• Knowledge of GTS licensing, UDI coordination, and EU MDR preferred.
• Developing customer service skills for interaction with various organizational levels and external contacts.
• Strong organizational and time management skills with attention to detail.
• Experience with Agile, Documentum, or other document management systems in the medical device or pharmaceutical industry.
• Proficiency in Microsoft Office Suite applications, including Outlook, Word, Excel, and Adobe Acrobat.
• Ability to quickly learn new software packages with minimal training.
• Familiarity with records management and archiving strategies.
• Developing written and verbal communication skills.
• Ability to work with established procedures and establish new processes as needed.
• Motivated self-starter capable of working independently or in teams in a fast-paced environment.
• Ability to work effectively in a matrix organization and partner with remote stakeholders.

Nice-to-haves

• Experience in the medical device or pharmaceutical industry.
• Familiarity with regulatory compliance processes.
• Experience in project management or process improvement.

Benefits

• Competitive salary and flexible benefits package.
• Wide range of benefits and resources to support employees at every career and life stage.